Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-05

Study Completion Date

2027-12-31

Brief Summary

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The objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the Evoke System in the treatment of chronic pain of the trunk and/or limbs in a real-world population.

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Detailed Description

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Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ECAP-controlled, closed-loop SCS

Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Evoke Spinal Cord Stimulation (SCS) System

Intervention Type DEVICE

A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Interventions

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Evoke Spinal Cord Stimulation (SCS) System

A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Eligible for therapy according to the Evoke System indications for use statement and labelling requirements
* Willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits
* Baseline VAS pain rating ≥60 mm in the primary area of pain

Eligible Sex

ALL

Accepts Healthy Volunteers

No